510(k) · Cleared
ClearedProlite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Bio Care Sweden AB · GEX Powered Laser Surgical Instrument
Cleared on Jan 8, 2002 after a 90-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1,127 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
1,127 later devices descend from it, 4 citing it directly.
- This deviceK013365 Prolite Pulsed Light System for the Treatment of Pigmented Lesions…Medical Bio Care Sweden AB · 2002
- Descendant · cites it directly · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- Descendant · 2 generations on · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003
Showing 5 of 1,127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,127 · See all- K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · cites it directly1,117descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 2 generations on678descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 2 generations on654descendants
- K032460Profile BBL SystemSciton, Inc · 2003 · 2 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013365 | Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the… | Medical Bio Care Sweden AB | 2002 | — |
| +1 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| +2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| +2 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 19 | 0 |
| 2007 | 27 | 0 |
| 2008 | 41 | 0 |
| 2009 | 33 | 0 |
| 2010 | 28 | 0 |
| 2011 | 32 | 0 |
| 2012 | 28 | 0 |
| 2013 | 46 | 0 |
| 2014 | 46 | 0 |
| 2015 | 38 | 0 |
| 2016 | 56 | 0 |
| 2017 | 51 | 0 |
| 2018 | 46 | 0 |
| 2019 | 41 | 0 |
| 2020 | 56 | 0 |
| 2021 | 55 | 0 |
| 2022 | 77 | 0 |
| 2023 | 71 | 0 |
| 2024 | 98 | 0 |
| 2025 | 130 | 0 |
| 2026 | 77 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060772 | FDA’s K060772 is Manuel Saftey Syringe Parts 1 & 2 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
What descends from it? (1,127)
See all 1,1274 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023954 (Altus Medical, Inc., 2003) has gone furthest, with 1,117 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013365
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026